Medical Device Manufacturer · US , San Jose , CA

Boston Scientific Corp - FDA 510(k) Cleared Devices

432 submissions · 411 cleared · Since 1988
432
Total
411
Cleared
0
Denied
432 devices
76-100 of 432
Cleared Dec 11, 2009
ACCUMAX
K093691 · GEX
General & Plastic Surgery · 11d
Cleared Sep 30, 2009
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL...
K092666 · HCG
Neurology · 30d
Cleared Jul 02, 2009
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
K090554 · DQX
Cardiovascular · 122d
Cleared Jun 09, 2009
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330,...
K091340 · FPD
Gastroenterology & Urology · 34d
Cleared Apr 22, 2009
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
K083374 · FGE
Gastroenterology & Urology · 160d
Cleared Feb 04, 2009
SPYSCOPE ACCESS AND DELIVERY CATHETER
K090170 · ODF
Gastroenterology & Urology · 12d
Cleared Feb 03, 2009
BLAZER DX-20 DIAGNOSTIC CATHETER
K081576 · DRF
Cardiovascular · 243d
Cleared Dec 03, 2008
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K081739 · KNT
Gastroenterology & Urology · 167d
Cleared Oct 27, 2008
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
K081733 · FGE
Gastroenterology & Urology · 130d
Cleared Oct 16, 2008
STRAIGHT FIRE HOLMIUM LASER FIBER
K082928 · GEX
General & Plastic Surgery · 15d
Cleared Aug 27, 2008
BOSTON SCIENTIFIC SURGICAL MESH
K081275 · PAH
Gastroenterology & Urology · 114d
Cleared Aug 22, 2008
PINNACLE PELVIC FLOOR REPAIR KIT II
K081048 · OTP
Obstetrics & Gynecology · 130d
Cleared Aug 08, 2008
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
K081021 · DQX
Cardiovascular · 120d
Cleared Jul 14, 2008
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS
K080982 · LIT
Cardiovascular · 98d
Cleared Mar 13, 2008
ATLANTIS 018 PERIPHERAL IMAGING CATHETER
K073623 · ITX
Radiology · 78d
Cleared Mar 11, 2008
ATLANTIS PVIMAGING CATHETER, MODEL H749364560
K080272 · ITX
Radiology · 39d
Cleared Mar 07, 2008
CONVOY ADVANCED DELIVERY SHEATH
K072719 · DYB
Cardiovascular · 164d
Cleared Feb 27, 2008
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
K073266 · ESW
Gastroenterology & Urology · 99d
Cleared Nov 08, 2007
PINNACLE PELVIC FLOOR REPAIR KITS
K071957 · OTP
Obstetrics & Gynecology · 115d
Cleared Sep 26, 2007
ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3
K072517 · IYO
Radiology · 19d
Cleared Jul 13, 2007
BLUE MAX BALLOON DILATATION CATHETER
K071309 · LIT
Cardiovascular · 65d
Cleared Jul 12, 2007
MODIFICATION TO:CONTOUR SE MICROSPHERES
K071634 · HCG
Neurology · 27d
Cleared Jun 29, 2007
SPYCATCH STONE RETRIEVAL BASKET
K071066 · LQR
Gastroenterology & Urology · 74d
Cleared Jun 13, 2007
POLARCATH PERIPHERAL DILATATION SYSTEM
K071042 · LIT
Cardiovascular · 62d
Cleared Dec 21, 2006
I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0
K063493 · IYN
Radiology · 31d

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